Trial Outcomes & Findings for To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213) (NCT NCT04629508)
NCT ID: NCT04629508
Last Updated: 2025-09-02
Results Overview
An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
up to 724 days
Results posted on
2025-09-02
Participant Flow
This study was conducted at 3 study centers in the United States and Italy.
Participant milestones
| Measure |
Itacitinib 300 mg
Participants received itacitinib immediate release 300 milligrams (mg) twice a day (BID) orally (PO) for at least 24 weeks. Participants could remain on treatment as long as they were receiving clinical benefit and had not met any criteria for treatment discontinuation.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Itacitinib 300 mg
Participants received itacitinib immediate release 300 milligrams (mg) twice a day (BID) orally (PO) for at least 24 weeks. Participants could remain on treatment as long as they were receiving clinical benefit and had not met any criteria for treatment discontinuation.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
2
|
|
Overall Study
Protocol-specified withdrawal criterion met
|
1
|
Baseline Characteristics
To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213)
Baseline characteristics by cohort
| Measure |
Itacitinib 300 mg
n=4 Participants
Participants received itacitinib immediate release 300 milligrams (mg) twice a day (BID) orally (PO) for at least 24 weeks. Participants could remain on treatment as long as they were receiving clinical benefit and had not met any criteria for treatment discontinuation.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: up to 724 daysPopulation: Safety Evaluable Population: all participants enrolled in the study who received at least 1 dose of study treatment
An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment.
Outcome measures
| Measure |
Itacitinib 300 mg
n=4 Participants
Participants received itacitinib immediate release 300 milligrams (mg) twice a day (BID) orally (PO) for at least 24 weeks. Participants could remain on treatment as long as they were receiving clinical benefit and had not met any criteria for treatment discontinuation.
|
|---|---|
|
Part 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
|
4 Participants
|
PRIMARY outcome
Timeframe: up to 724 daysPopulation: Safety Evaluable Population
A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Outcome measures
| Measure |
Itacitinib 300 mg
n=4 Participants
Participants received itacitinib immediate release 300 milligrams (mg) twice a day (BID) orally (PO) for at least 24 weeks. Participants could remain on treatment as long as they were receiving clinical benefit and had not met any criteria for treatment discontinuation.
|
|---|---|
|
Part 1: Number of Participants With Any Grade 3 or Higher TEAE
|
4 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 24Population: Analysis was not conducted because Part 2 never opened for enrollment.
SRR was defined as the percentage of participants who had a reduction in spleen volume (by imaging) of at least 35% when compared with Baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to at least 24 weeksPopulation: Analysis was not conducted because Part 2 never opened for enrollment.
An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to at least 24 weeksPopulation: Analysis was not conducted because Part 2 never opened for enrollment.
A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Analysis was not conducted because Part 2 never opened for enrollment.
TSS response was defined as the percentage of participants who achieved at least 50% reduction in TSS over the 28 days immediately before the end of Week 24 compared with the 7 days immediately before the initiation of itacitinib immediate release (aseline).B
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Weeks 12 and 24Population: Analysis was not conducted because Part 2 never opened for enrollment.
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) was to be used to assess the improvement in quality of life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Analysis was not conducted because Part 2 never opened for enrollment.
The PGIC consists of a single question pertaining to a participant's overall status since the start of the study. The questionnaire gives participants 7 options to describe their overall status including: very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse.
Outcome measures
Outcome data not reported
Adverse Events
Itacitinib 300 mg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
Total
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Itacitinib 300 mg
n=4 participants at risk
itacitinib 300 mg
|
Total
n=4 participants at risk
Total
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Cardiac disorders
Atrial fibrillation
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Immune system disorders
Cytokine storm
|
25.0%
1/4 • Number of events 2 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 2 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Infections and infestations
Enterocolitis infectious
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
25.0%
1/4 • Number of events 2 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 2 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Vascular disorders
Shock haemorrhagic
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
Other adverse events
| Measure |
Itacitinib 300 mg
n=4 participants at risk
itacitinib 300 mg
|
Total
n=4 participants at risk
Total
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • Number of events 2 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 2 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
General disorders
Asthenia
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Investigations
Blood creatinine increased
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Infections and infestations
Candida infection
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Cardiac disorders
Cardiac failure
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
50.0%
2/4 • Number of events 2 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
50.0%
2/4 • Number of events 2 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Renal and urinary disorders
Nephropathy toxic
|
50.0%
2/4 • Number of events 4 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
50.0%
2/4 • Number of events 4 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Cardiac disorders
Sinus bradycardia
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Nervous system disorders
Syncope
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
|
25.0%
1/4 • Number of events 1 • up to 724 days
Treatment-emergent adverse events (TEAEs), defined as AEs that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, were reported for the Safety Evaluable Population.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER